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NCT Number: NCT06613269

68Ga-NY104 PET/CT Guided Radiation Therapy in CcRCC.

Radiation therapy (RT) is an effective treatment for patients with advanced-stage clear cell renal cell carcinoma (ccRCC). Current evidence has shown promising outcomes combining radiation therapy and standard systemic therapy in patients with metastatic/recurrent ccRCC. CAIX is a highly sensitive and specific biomarker expressed on ccRCC and in previous studies the investigators have shown excellent diagnostic efficacy of 68Ga-NY104, a CAIX-targeted PET tracer, in patients with metastatic ccRCC. In this study, the investigators aim to investigate the effect of 68Ga-NY104, and 18F-FDG PET/CT guided RT combining standard systemic therapy in patients with metastatic ccRCC.

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Key information

Conditions

Clear Cell Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old
  • Histologically or cytologically confirmed clear cell renal cell carcinoma
  • Eligible for radiation therapy: no more than 10 lesions in total
  • Expected survival: over 3 months
  • ECOG: 0 or 1
  • Sufficient organ function
  • Written informed consent

Exclusion criteria

  • Brain metastasis/carcinomatous meningitis
  • Other malignant tumors that are not controlled within 5 years, except for non-metastatic low-risk prostate cancer.
  • Pregnant or breastfeeding.
  • Active infection.

Treatment and study plan

68Ga-NY104 PET/CT

Drug

68Ga-NY104 PET/CT will be performed at baseline, 6 months, 12 months, and 24 months after radiation therapy if the tumor is under control. If CT or MRI shows any suspicious recurrence or metastasis, 68Ga-NY104 PET/CT can be performed at the decision of the urology oncologist or radiation oncologist.

The scan begins 1 hour after intravenous injection of 68Ga-NY104.

18F-FDG PET/CT

Drug

18F-FDG PET/CT will be performed at baseline and 6 months after radiation therapy. The scan begins 1 hour after intravenous injection of 18F-FDG.

radiation therapy

Radiation

Radiation therapy will be delivered to cover as much metastasis as possible if not all. For new lesions after radiation plus systemic therapy, if the new lesions are considered suitable for RT, RT can be delivered again without changing systemic therapy.

Systemic therapy

Drug

Systemic therapy will be delivered to patients to control the tumor. Possible regimen includes targeted therapy alone, immunotherapy alone, and targeted therapy combined with immunotherapy. The treatment regimen will be decided according to the urology oncologist.

Primary outcomes

  1. Progression free survival 2, PFS2

    Time frame: the time from the start of RT to 4 years after treatment

    Progression Free Survival 2 (PFS2) was defined as the time from the beginning of treatment to the emergence of new lesions or the progression of original lesions, when the lesions could not be fully covered by radiotherapy, and the drug regimen had to be changed.

Secondary outcomes

  1. Lesion uptake on 68Ga-NY104 PET/CT

    Time frame: From the start of 68Ga-NY104 PET/CT to 1 week after the 68Ga-NY104 PET/CT

  2. Lesion uptake on 18F-FDG PET/CT

    Time frame: From the start of 18F-FDG PET/CT to 1 week after the 18F-FDG PET/CT

  3. Number of positive lesions detected on 68Ga-NY104 PET/CT

    Time frame: From the start of 68Ga-NY104 PET/CT to 1 week after the 68Ga-NY104 PET/CT

  4. Number of positive lesions detected on 18F-FDG PET/CT

    Time frame: From the start of 18F-FDG PET/CT to 1 week after the 18F-FDG PET/CT

  5. Number of lesions detected combining all available imaging modalities

    Time frame: From the start of any imaging modality to 1 week after completion of all imaging modalities

  6. Objective response rate

    Time frame: the time from the start of RT to 4 years after treatment

    The percentage of patients with complete remission or partial remission of tumor after treatment.

  7. Progression free survival 1, PFS1

    Time frame: the time from the start of RT to 4 years after treatment

    Progression Free Survival 1 (PFS1) was defined as the time from the beginning of treatment to the emergence of new lesions or the progression of original lesions.

  8. Disease control rate

    Time frame: the time from the start of RT to 4 years after treatment

    The percentage of patients with complete remission, partial remission, or stable disease after treatment.

  9. Overall survival

    Time frame: the time from the start of RT to 4 years after treatment

  10. Adverse event

    Time frame: the time from the start of RT to 4 years after treatment

    The adverse event due to PET/CT and treatment will be recorded according to CTCAE 5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Mingwei Ma, MD

CONTACT

[email protected]

+86 0108372408

Xianshu Gao, MD

CONTACT

[email protected]

+86 01083575641

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Peking University First Hospital

Registry information

Official study title

Effect of 68Ga-NY104 and 18F-FDG PET/CT Guided Radiation Therapy Combined with Systemic Treatment in Patients with Clear Cell Renal Cell Carcinoma.

Acronym: NYCRRT

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Sep 25, 2024
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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